Clinical trial

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect, and Ethnicity Effect of SB17170 in Healthy Adult Subjects

Name

SMARTT-002

Description

This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.

Trial arms

Trial start

2023-05-24

Estimated PCD

2024-02-29

Trial end

2024-03-15

Status

Completed

Phase

Early phase I

Treatment

SB17170

Taking SB17170 orally once a day

Arms:

SB17170 of 1000mg, Multiple dose for 7days, SB17170 of 1000mg, Single dose, SB17170 of 1500mg, Single dose, SB17170 of 150mg, Single dose, SB17170 of 250mg, Multiple dose for 7days, SB17170 of 250mg, Single dose, SB17170 of 500mg, Multiple dose for 7days, SB17170 of 500mg, Single dose, Food-effect, SB17170 of 50mg, Single dose

Placebo

Taking Placebo orally once a day

Arms:

Placebo of 1000mg, Multiple dose for 7days, Placebo of 1000mg, Single dose, Placebo of 1500mg, Single dose, Placebo of 150mg, Single dose, Placebo of 250mg, Multiple dose for 7days, Placebo of 250mg, Single dose, Placebo of 500mg, Multiple dose for 7days, Placebo of 500mg, Single dose, Food-effect, Placebo of 50mg, Single dose

Size

Primary endpoint

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose

Eligibility criteria

Inclusion Criteria: * Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent * Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 * Written informed consent Exclusion Criteria: * Clinical significant medical history * Gastrointestinal disease or past history * Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs * Screening test AST, ALT \> ULN x 1.5 Creatinine clearance \< 60mL/min/1.73m2 QTcB interval \> 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV) * SBP \<90 mmHg or \>150 mmHg, DBP \<60 mmHg or \> 100 mmHg * Drub abuse history * Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks * Participation in other clinical trial within 6 months

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Block randomized, double-blind design controlling with IWRS', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

Updated at

2024-03-21

1 organization

2 products

4 indications

Organization

Product

Indication

Indication

Indication

Indication

Product